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Phase 3
Age: 18Years - 65Years
All Genders
ID07168434

Evaluating Saccharomyces Boulardii CNCM I-745 for Treating Non-constipated Irritable Bowel Syndrome in Adults Aged 18 to 65

Led by Biocodex · Updated on 2025-11-18

406

Participants Needed

10

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the effects of Saccharomyces boulardii CNCM I-745 on adults with non-constipated Irritable Bowel Syndrome IBS. This study aims to compare the impact of this probiotic to a placebo on overall IBS symptoms using the Irritable Bowel Syndrome Symptom Severity Scale IBS-SSS after 8 weeks. The trial also evaluates quality of life improvements and safety in IBS patients over a 3-month treatment period. Participants will be randomly assigned to receive either Saccharomyces boulardii CNCM I-745 capsules, 250 mg twice daily, or placebo capsules at the same dose and schedule. This double-blind study will last about 13.5 months in total, with treatment lasting 3 months and various assessments at baseline, 28, 56, and 84 days. During the study, participants will complete symptom severity scales and quality of life questionnaires at regular intervals. Researchers will monitor safety through recording adverse events, changes in pulse rate, blood pressure, and body weight. The main outcome is the change in IBS symptom severity after 8 weeks, with additional evaluations over the full treatment period to assess response and tolerance.

CONDITIONS

Brief Title

Saccharomyces Boulardii CNCM I-745 in Irritable Bowel Syndrome

Research Team

E

Elise Miclot

H

Hugo-Miguel Dachez De Oliveira

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